OUTLINE: Patients receive NY-ESO-1/LAGE-1 peptide vaccine subcutaneously every other week for 12 weeks in the absence of disease progression or unacceptable toxicity. The initial cohorts of patients are treated with one course of either MHC Class I-binding or MHC Class II-binding peptides. If these Class I or Class II binding peptides are safe individually, subsequent cohorts of patients with appropriate HLA type receive both types of peptides in combination.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

A 50% increase in PSA level from the nadir PSA level confirmed twice and measured at least 2 weeks apart, with stable and measurable disease

Castrate serum levels of testosterone < 50 ng/dL

If patient was receiving anti-androgen therapy, in addition to luteinizing hormone-releasing hormone (LHRH) agonist therapy, the evidence of progressive disease should persist after a trial of anti-androgen withdrawal

Treatment with LHRH agonist to maintain androgen ablation must continue throughout this trial

Baseline PSA ≥ 10 ng/mL

All patients with androgen-independent prostate cancer and matched HLA typing are eligible for vaccination regardless of initial NY-ESO-1 expression status

No concurrent immunosuppressive drugs such as systemic corticosteroids

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616291